MAUDE Adverse Event Report: THE SPECTRANETICS CORPORATION SPECTRANETICS LEAD LOCKING DEVICE; LLD

Model Number 518-062

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Iatrogenic Source (2498); No Known Impact Or Consequence To Patient (2692)

Event Date 07/16/2018

Event Type  Injury  

Manufacturer Narrative

Device lot number and expiration date unavailable.Device manufacture date unavailable.

Event Description

Lead extraction procedure commenced to remove two leads: a right atrial (ra) lead and a right ventricular (rv) lead from a frail, elderly patient, due to infection.A glidelight device, model 500-302 along with lld devices were in use.The physician attempted extraction of the rv lead first; however stalled progression was encountered at the subclavian/innominate junction.Attention was then turned to attempted removal of the ra lead.There was smooth progression down the lead and the lead came free; however, at this time the patient's blood pressure dropped.Rescue efforts commenced immediately, including sternotomy and extensive intervention.A 2cm superior vena cava (svc) tear was identified and successfully repaired.However, while attempting to remove the remaining rv lead with use of a 11f tightrail device, an additional tear of the svc was discovered which was an extension of the original tear, around 3cm in length, laterally into the right atrium.This area was repaired and the physician chose to cut and cap the lld and rv lead due to the poor prognosis of the patient.Despite successful repairs, the patient died on (b)(6) 2018.This mdr is being submitted for the spectranetics lld device that was cut and capped within the rv lead, as the lld is not an implantable device.This cut/cap of the lld and rv lead did not cause or contribute to this patient's death; the patient's injuries related to her death were likely caused or contributed to by another device used during this procedure.

• Brand Name: SPECTRANETICS LEAD LOCKING DEVICE
• Type of Device: LLD
• Manufacturer (Section D): THE SPECTRANETICS CORPORATION; 9965 federal drive; colorado springs CO 80921
• Manufacturer Contact: barbara creel ; 9965 federal drive; colorado springs, CO 80921 ; 719447-246
• MDR Report Key: 7747433
• MDR Text Key: 115944244
• Report Number: 1721279-2018-00101
• Device Sequence Number: 1
• Product Code: DRB
• UDI-Device Identifier: 00813132023072
• UDI-Public: 00813132023072
• Combination Product (y/n): Y
• Reporter Country Code: US
• PMA/PMN Number: K990713
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 01/01/2005,07/16/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 518-062
• Device Catalogue Number: 518-062
• Device Lot Number: UNAVAILABLE
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 01/01/2005
• Date Report to Manufacturer: 01/10/2005
• Initial Date Manufacturer Received: 07/16/2018
• Initial Date FDA Received: 08/03/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: SPECTRANETICS 14F GLIDELIGHT LASER SHEATH; SPECTRANETICS CVX-300 EXCIMER LASER; SPECTRANETICS TIGHTRAIL ROTATING DILATOR SHEATH
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 90 YR
• Patient Weight: 47